What the trial was testing
The ROAR enrolled 206 patients with biliary tract cancer. The study was sponsored by Novartis Pharmaceuticals and tracked outcomes across the full group of patients who matched the trial's eligibility profile.
It was initial testing (phase 2). Trials at this stage are designed to produce evidence regulators and physicians can act on — not just observations to follow up later.
What the results showed
About 50% tumor response rate in BRAF-mutant biliary tract cancer.
The Lancet Oncology · 2020 · NCT02034110
These findings — that in advanced BRAF-mutant biliary tract cancer on dabrafenib plus trametinib — were published in the The Lancet Oncology and represent the headline result of the study.
Researchers tracked outcomes across 206 patients enrolled in the trial. The result was consistent enough across the group that the team felt confident reporting it.
What this means for patients
For patients with biliary tract cancer, this result changes the calculus on what to ask their care team about. Whether it changes day-to-day care depends on factors like disease subtype, prior treatments, and where the patient is in their care journey.
What you can do now
Dabrafenib (Tafinlar) plus trametinib (Mekinist) is FDA-approved for any solid tumor with a BRAF V600E mutation, including biliary tract cancer, and available now. Ask an oncologist about BRAF testing on your tumor — most centers test routinely for advanced bile duct cancer.
Eligibility for the treatments mentioned above depends on specific test results and clinical history. Bring this summary, the trial name, and your most recent labs or pathology report to your next visit.
Open biliary tract cancer trials
S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletion of MTAP
This is a first-in-human Phase 1/2, multicenter, open-label study of S095035 as single-agent, or in combination with TNG462 in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP who have failed to respond to or have progressed after at least 1 prior treatment regimen, and for whom additional effective standard treatment is not available. S095035 is an oral methionine adenosyltransferase 2A \[MAT2A\] inhibitor. TNG462 is a protein arginine N-methyltransferase 5 \[PRMT5\] inhibitor.
Y-90 With Durvalumab/Gem/Cis in Intrahepatic Cholangio
This trial is designed to study a combination of interventions (chemotherapy, immunotherapy, and radiation) as a potential new treatment for bile duct cancer that cannot be removed with surgery. The specific names of the interventions that will be used are: * Y-90 (a type of radiation microsphere bead) * Durvalumab (a type of immunotherapy) * Gemcitabine (a type of chemotherapy) * Cisplatin (a type of chemotherapy)